N/A
Completed N=315
ForgIng New Paths to Prevent DIabeTes (FINDIT)
Source: ClinicalTrials.gov NCT02747108 ↗Enrolled (actual)
315
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Weight Change From Baseline to 12 Months — -.995535; -2.1333341; .039778; -4.17 Pounds
Summary
This study will evaluate the effects of screening for type 2 diabetes mellitus (T2DM) and brief counseling about screening test results on weight and key health behaviors among Veterans with risk factors for T2DM. Study participants will be randomly assigned to one of two study groups: (1) Blood Test Group or (2) Brochure Group. Participants in the Blood Test Group will complete a blood test called hemoglobin A1c (HbA1c) which measures average blood sugar levels. Participants will receive brief counseling about the results from their primary care provider or someone authorized to speak on their behalf. Participants randomly selected for the Brochure Group will review a handout from the VA National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations. All participants will be asked to complete a survey prior to study group assignment, immediately after a Primary Care appointment, 3 months after enrollment, and 12 months after enrollment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change From Baseline to 12 Months |
-.995535; -2.1333341; .039778; -4.17 | — |
| SECONDARY Change in Use of Medication for T2DM Prevention |
0; 3; 0; 3; 134; 59 | — |
| SECONDARY Changes in Participation in a Weight Management Program |
17; 8; 8; 2; 117; 54 | — |
| SECONDARY Changes in Perception for Risk for T2DM |
20.775; 21.724; 27.596; 35.455; 16.356; 23.684 | — |
| SECONDARY Changes in Knowledge of Strategies to Prevent T2DM |
1.03; 1.10; 1.34; 1.09; 1.04; 1.01 | — |
| SECONDARY Changes in Motivation to Prevent T2DM |
6.618; 7.237; 6.676; 6.455; 6.558; 7.246 | — |
| SECONDARY Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM |
4.869; 5.082; 4.747; 4.341; 4.926; 5.005 | — |
| SECONDARY Change in Physical Activity |
.542; .5; .495; .273; .45; .517 | — |
| SECONDARY Change in Mental Health |
44.995; 44.264; 45.373; 37.926; 46.366; 46.389 | — |
Eligibility Criteria
Inclusion Criteria
The investigators will recruit 315 non-diabetic Veterans receiving primary care at the Ann Arbor VA Medical Center who meet the following inclusion criteria:
- willing to complete a HIPAA authorization form
- no HbA1c results in previous 12 months
- due for VA Primary Care appointment approximately 12 weeks of sending a recruitment letter and who have a body-mass index (BMI) 30 kg/m2
- or BMI 25 kg/m2 with > 1 obesity-related condition such as:
- hypertension
- hyperlipidemia
- Hypoalphalipoproteinemia
- Coronary Artery Disease
- Peripheral Vascular Disease
- Hypertriglyceridemia
- past hemoglobin A1c (HbA1c) of 5.7 - 6.4
- past diagnosis of Impaired Fasting Glucose (IFG)
- or Impaired Glucose Tolerance (IGT)
- or Polycystic Ovary Syndrome (PCOS)
Exclusion Criteria
- The investigators will exclude patients who are > 75 years of age
- are receiving chemotherapy for cancer, or have:
- dementia
- diabetes
- dementia
- New York Heart Association Class III or IV congestive heart failure
- pregnancy
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 4 Chronic Obstructive Pulmonary Disease (COPD)
- end-stage renal disease (ESRD)
- cirrhosis
- or have been hospitalized or received rehab for stroke or myocardial infarction within the past 6 months
Data sourced from ClinicalTrials.gov (NCT02747108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.